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Logo of Phnom Penh Post newspaper Phnom Penh Post - Sides in HIV-drug-testing debate volley in Geneva

Sides in HIV-drug-testing debate volley in Geneva

Almost one year after the Cambodian Ministry of Health suspended a controversial

drug trial on 960 HIV-free sex workers, the possibility of testing other HIV prevention

drugs in Cambodia is still being discussed.

A series of ongoing meetings sponsored by the Bill and Melinda Gates Foundation and

UNAIDS, the joint UN program on HIV/AIDS, is meant to encourage communication between

researchers and the communities where the drugs are being tested. The first meeting

took place June 20-21 in Geneva, and a comprehensive report on international consultation

of HIV anti-retroviral drug testing will be published by UNAIDS after the final meeting

in October.

"There was little understanding between the researchers and the research subjects

in the first proposed trial," said Dr. Tia Phalla, Seceratary-General of the

National AIDS Authority in Cambodia. "There needs to be a good understanding

and recourse from damages caused during the trial, because nobody knows what could

happen upon testing the drug."

The last proposed trial - a $2.1 million trial of the HIV retro-viral drug Tenofovir,

funded by the US National Institute of Health and the Bill Gates Charity foundation

- was rejected after protests from local NGOs and sex workers and criticism from

the Cambodian government

"Cambodia is not a trash bin country," Prime Minister Hun Sen said at a

ceremony for the expansion of the Kantha Bopha I Hospital in Phnom Penh last August.

"They should not conduct experiments with Cambodians. They should do it with

animals."

Since the suspension of the Tenofovir trials last August, two similar multi-million

dollar trials have been suspended in Cameroon and Nigeria. In Cambodia, the trial

was stopped before it started, but in Cameroon and Nigeria the trials were already

underway when they were halted for inadequate counseling and medical care.

Tenofovir is currently being tested in Botswana, Ghana, Peru, Thailand and the United

States.

In search of new methods to combat the disease, HIV-drug researchers, pharmaceutical

companies and many aid and governmental organizations emphasize the need to expand

preventative-HIV-drug trials to humans

Cambodia was selected for testing Tenofovir because it currently has one of the highest

HIV infection rates in Southeast Asia. According to UNAIDS, 160,000 people between

15 and 49 have HIV in Cambodia. The government expects total deaths from AIDS-related

diseases to reach 230,000 by 2010.

"Tenofovir, if proven efficacious and safe, could save the lives of millions

of uninfected individuals," said Emmanuel Trenado, Director of International

Progarms at AIDES, a French, community-based organization combating HIV in Cambodia.

"The issue is the way trials are conducted."

"There are no ethical dilemmas of human testing, simply arrogant sponsors who

are reluctant to conduct research differently," Trenado said.

Trenado cites community involvement, access to anti-retroviral therapy (ART) for

individuals and volunteers who become infected during the trial, counseling, and

distribution of proven risk reduction methods, such as condoms, as the minimum requirements

to ensure the rights and safety of the people tested.

The Geneva meeting was put together to allow communities to participate in preventative-HIV-drug-testing

research and start communication between different stakeholders about the way trials

should be conducted.

"If we do not have any research, we won't have any progress," UNAIDS Cambodia

country coordinator Geeta Sethi said. "There is the need to communicate about

the perceived benefits and costs of such trials."

Ironically, the harshest critic of the previous drug trials, the Women's Network

for Unity (WNU) - often referred to as the prostitutes' union - was the sole Cambodian

delegate present at the meeting.

"The debate over Tenofovir trials in Cambodia is over. We have already rejected

the trials," said Sou Sotheavy, the WNU delegate chosen to attend the meeting.

"The purpose of the conference was to discuss any kind of drug testing in the

future."

The WNU protested Tenofovir testing last year because researchers and funders of

the drug made by California-based pharmaceutical company Gilead Inc. would not meet

their demands of a 30- to 40-year post-study protection plan.

Delegates attending the meeting ranged from community-based NGOs and activists to

researchers and funders from 20 countries on five continents. Each country raised

new ideas but offered no solutions to bridge divides between communities and researchers

have yet been made.

Sotheavy said many of the delegates agreed on similar testing requirements, which

may be reflected in the report next October. These include the need for researchers

to develop drug trials and communicate with communities for two years before beginning

trials; mandatory 30-year post-study protection and medical plans including free

ART; and the building of clinics in host countries where all research and post-study

medical care will be conducted.

"If a pharmaceutical company accepts Cambodia's requirements for testing, drug

trials could be a great benefit to Cambodian sex workers and to the country in general,"

Sotheavy said.

Dr. Phalla said that the need for HIV drug trials in Cambodia and other low-income

countries is especially great because of gender inequality.

"It is very difficult to oblige condom use in Cambodia and encouraging condom

use with husbands sometimes causes aggression," said Dr. Phalla. "So a

preventative drug is another way that women would have a means to protect themselves."

Husbands who visit brothels and then infect their wives are a significant cause of

HIV transmission. These women can in turn pass the disease on to future children.

Cambodia's $15 million annual budget to fight the epidemic has been spent primarily

on condom distribution, sex education, blood tests, and patient care.

"We are in need of international sponsors to test preventative HIV drugs,"

Dr. Phalla said. "But we need to observe the guidelines of the Ministry of Health

for any drug testing in this country."

Dr. Mean Chhi Vun, Director of the National Center for HIV/AIDS, Dermatology and

STIs (NCHDS) was unwilling to comment on the future of drug trials in Cambodia until

NCHDS has further knowledge about specific proposals.

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